Sterility Testing Of Products To Be Diluted In Isopropyl Myristate

While membrane filtration is the preferred method for sterility testing according to pharmacopoeias, viscous products like creams and ointments pose a challenge. These products often require dilution with sterile solvents like isopropyl myristate (IPM) for proper filtration. However, testing such diluted samples can be tricky without specific procedures and equipment.

The Steritest® NEO device TZHVSL210 is ideal for handling solvents, creams, ointments, and even veterinary injectables. Its key features include:

• Solvent-resistant nylon canister
• Durapore® (PVDF) membrane for efficient filtration
• Reinforced base structure for stability
• Secure canister connection to minimize leaks

This application note outlines a potential test method for diluting a product in IPM, filtering it, and rinsing the membrane to remove residues that could hinder microbial growth. Depending on the specific product, adjustments might be necessary to ensure the method successfully passes the required suitability test.